Aug 11, 2017  |  Posted by: 

Cleaning Validation is a critical regulatory requirement in the pharmaceutical, biotechnology and medical device industry. The purpose of cleaning validation is to establish evidence that the cleaning process will consistently yield results that meet predetermined specifications. The goal of the cleaning process is to remove the following:
  • All components from the previous product
  • Bioburden
  • Endotoxins
  • Deter...  
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Jul 26, 2017  |  Posted by: 

Leveraging the power of a Validation Lifecycle Management System (VLMS)

According to FDA 820.3(z) “Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.” Ironically, the actual provision of objective evidence is subjective. Before we continue let’s call to mind the difference between subjective versus objective. A su...  
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Jun 29, 2017  |  Posted by: 

In the life science industry, all computer systems with GMP impact must be validated. Computer System Validation is intended to provide documented evidence that a computer system meets documented user requirements. User requirements need to be traceable to individual validation test using a traceability matrix. Unfortunately creating a traceability matrix manually is a very inefficient time consuming process that requires a lot of effort to maintain ...  
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May 25, 2017  |  Posted by: 

Leveraging Technology to Address the ALARP vs AFAP Challenge

It is a regulatory requirement for Medical Device companies to perform Risk Management and provide documented evidence to demonstrate compliance with regulation and a company’s own Quality Management System (i.e., Policy & Standard Operating Procedures). Expectations are stipulated in ISO 14971: Medical devices – Application of Read more »

May 05, 2017  |  Posted by: 

In the pharmaceutical, biotechnology and medical device industry equipment validation traditionally is a manual inefficient paper-based process that is plagued with bottle necks and high cost. The inefficiencies found in traditional equipment validation are related to manual activities such as routing documents for review, approval, printing, scanning, storing and archiving paper-based equipment validation documents. There is a significant amount of chal...  
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Apr 28, 2017  |  Posted by: 

A Different Way of Thinking to Improve Validation!

Traditionally, Validation focuses validating something (i.e., an Entity), such as equipment, a computer system, a process, etc. A lot of paper is generated (e.g., VP, IQ, OQ, PQ, RTM). Then the validation package is filed away, typically only pulled during an audit.
The problem is that the same things are continually recreated. Inconsistencies arise, and valuable information is los...  
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Apr 05, 2017  |  Posted by: 

In the life science industry computer validation is typically a manual paper-based process that is plagued with inefficiencies and high cost. The inefficiencies are related to manual activities such as printing and scanning computer validation documents. There is a significant amount of challenges and risk related to paper-based computer validation such as the compliance risk associated to paper. The compliance risk related to paper-based validation ...  
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Mar 21, 2017  |  Posted by: 

Paperless Validation Paperless validation systems were introduced to the industry 10 years ago. Early in the lifecycle of these technology paperless validation system provided standard document management and electronic execution capabilities. This basic funct...  
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